How to run a laboratory: CLIA-waived office-based lab requirements

For example, many medical practices are now taking a population-based approach with patients who have diabetes or take warfarin. This includes adding office-based programs and policies beyond the standard physician visit that support improved outcomes for these groups of patients. These changes include requiring increased monitoring of blood glucose or INR levels.

But if you ask patients to take a more active role in their own care via increased testing, won’t that adversely affect patient satisfaction? On the contrary, physician office lab testing supports improved patient satisfaction, an important performance metric in today’s value-based care environment.^1,2

You may also find that providing POC testing in your office supports increased operational efficiency. With results in hand sooner, you can move on to diagnosis and treatment promptly. This helps to encourage better patient compliance and, ultimately, better health outcomes. Managed appropriately, testing can also serve as an additional revenue stream for the practice.

Know your practice, know your goals

Once you’ve determined that offering physician office lab testing in your practice would help you improve the quality of care your patients receive, you’ll need to start digging more into the logistics and requirements of your potential point-of-care (POC) testing venture.

Your answers to the following questions can help you determine the financial feasibility and optimal approach when implementing a new laboratory:

• What are your goals for your practice?
• What patient populations do you expect to grow within the practice?
• What do you want your patient experience to be like within your practice?
• What human resource constraints do you have?
• What specific test menus do you need?
• What daily or weekly test volumes do you anticipate?
• What operational efficiencies do you need to resolve?

Your answers to these questions can guide your path through learning about the regulatory and staffing requirements of running your own lab.

The basics of CLIA & testing types

The Clinical Laboratory Improvement Amendments (CLIA) are federal regulatory standards that apply to all clinical laboratory testing performed on humans in the U.S. (except clinical trials and basic research).³

According to CLIA, a clinical laboratory is any facility that performs laboratory testing on specimens obtained from humans for the purpose of providing information for health assessment and for disease diagnosis, prevention or treatment. Prior to patient testing, laboratories must have a CLIA license.

The FDA categorizes diagnostic tests by their complexity (not necessarily by the instrument) as CLIA-waived, moderate complexity and high complexity. There are five types of CLIA certificates that allow a lab to perform specific types of tests:

• Certificate of Waiver
• Certificate of Provider Performed Microscopy Procedures (PPM)
• Certificate of Registration
• Certificate of Compliance
• Certificate of Accreditation

The license type most labs start out with is a Certificate of Waiver, which will enable your lab to perform only CLIA-waived tests.⁴

Some states have additional licensure requirements, which may also involve an onsite inspection, before issuing your license. It is important to double-check the requirements of the state in which your practice operates.

You’ll also want to know the basic types of technology available for point-of-care lab testing.

• Rapid tests are generally read visually and inexpensive and easy to perform. They are operator-read and provide quick results, but this can be the least reliable type of test
• Reader technology reduces the possibility of human error in interpreting results by using analyzers that read and provide results to the clinician. Analyzers are often smaller, handheld devices that require minimal physical space. Although slightly more expensive initially, analyzers’ reliability quickly offsets their additional expense
• Molecular technology provides the highest degree of reporting accuracy. For years, it was available only with highly complex equipment, but advances in technology now allow for molecular testing at the initial point of care — right at the physician office — with a broad, quickly expanding menu of rapid and reader tests available

CLIA-waived testing in your practice

Many practices do at least some CLIA-waived testing, such as dipstick urinalysis, glucose tests using a glucometer or flu testing. To conduct CLIA-waived testing within a practice, the test manufacturer either needs to offer training or staff members can closely review the instructions provided within the FDA-approved package insert.

Your practice must follow all manufacturer instructions precisely in order to retain its CLIA waiver. There are implications if changes are made to a test system or to the manufacturer’s instructions for intended use that affect the test’s performance specifications for accuracy, precision, sensitivity or specificity. The modified test becomes “high complexity” under CLIA, requiring more rigorous validations.

Importantly, staff members who perform CLIA-waived testing don’t require any special certifications or degrees beyond a high school diploma.⁵ This flexibility allows most physician offices to perform some degree of HbA1c, strep or flu testing using the skills of a medical assistant or nurse.

Some states have imposed additional regulations. Verify whether your state has any additional requirements.